Monitoring of a time period relating to a product

ABSTRACT

A label includes a timer to monitor a predetermined time period relating to a medical device, such as an indwelling cannula, or other product. The label includes a signalling apparatus that provides an alert signal on expiry of the predetermined time period and a fixing portion to fix the label to a support surface such as medical records of a patient. The label can have a first portion and a second portion and the first portion can be separable from the second portion. The fixing portion can be provided in the second portion and all or part of the signalling apparatus provided in the first portion. Also disclosed is a monitoring system for a medical device, including a base station and a label receivable by the base station. The monitoring system monitors a predetermined time period based on receipt of the label by the base station.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/363,417, filed Nov. 29, 2016, which is acontinuation-in-part of International Application No. PCT/AU2015/050277,filed on May 26, 2015, which claims priority to Australian ProvisionalPatent Application No. 2014902045, filed on May 29, 2014, and AustralianProvisional Patent Application No. 2014903936, filed on Oct. 2, 2014,the disclosures all of which are incorporated herein by reference.

TECHNICAL FIELD

The present disclosure pertains to monitoring of a time period relatingto a product, e.g., a medical product such as a medical device or apharmaceutical, in order, for example, to reduce the risk of a patientcontracting an infection or suffering other harm through prolonged useof the product.

BACKGROUND

Despite stringent hospital guidelines for controlling the spread ofbacteria, hospital-acquired infections, also known ashealthcare-associated infections or “HAIs”, are commonplace. HAIs resultin unnecessary suffering for patients, extended healthcare and hospitaltimes and significant costs to healthcare systems.

A significant proportion of HAIs are caused through use of indwellingmedical devices that are inserted in patients for longer than a safetime period. For example, an intravenous cannula can be inserted in apatient's vein to deliver fluids, drugs or medical instruments. However,the intravenous cannula can also act as a conduit for bacteria to enterthe human body and can provide a protected environment for bacterialincubation, leading to HAIs. With approximately 1.5 billion cannulaeimplanted in patients globally each year, reducing the number of HAIscaused by cannulae and other medical devices, such as urethralcatheters, is paramount.

Any discussion of documents, acts, materials, devices, articles or thelike which has been included in the present specification is not to betaken as an admission that any or all of these matters form part of theprior art base or were common general knowledge in the field relevant tothe present disclosure as it existed before the priority date of eachclaim of this application.

SUMMARY

According to an aspect of the present disclosure, there is provided alabel comprising:

a timer to monitor a predetermined time period relating to a product;

a signalling apparatus that provides an alert signal on expiry of thepredetermined time period; and

a fixing portion to fix the label to a support surface.

The product may be a medical device or other type of product. The labelmay be considered a medical label or medical device label, for example.In one embodiment, the support surface is provided by medical records ofa patient. In another embodiment, the support surface is provided by acontainer.

The medical device, relating to which the predetermined time period maybe monitored, may be a device that is at least partially inserted in orplaced on a patient for a period of time. For example, the medicaldevice may be an indwelling medical device, such as an invasive conduitor cannula. Example medical devices include intravenous cannulae andurethral catheters. The medical device may be located in a patientintravenously, intravascularly, intra-arterially, intracranially,intra-urethrally or otherwise. The predetermined time period may be amaximum period that is considered safe for indwelling of the medicaldevice. The predetermined time period may be based on pre-existingmedical standards, protocols or regulations. Upon expiry of thepredetermined time period, it may be understood that the risk of thepatient developing an infection (e.g., an HAI) is increased to anunacceptable level.

The medical device is not necessarily an invasive device or a devicethat may increase risk of infection, however. The medical device may beany medical device for which monitoring of a predetermined time periodis desired. For example, the medical device may be a compression bandagethat should be removed within a specific period of time, or a drugdelivery patch that should be removed within a specific period of time.As another example, the medical device may be a hospital bed, wherein apatient lying on the bed should be encouraged to move periodically toavoid pressure sores.

By providing a label that includes a timer to monitor the predeterminedtime period, the label can provide an indication to a user, such as anurse, clinician or other medical practitioner, or in some instances tothe patient themselves, that a particular action needs to be taken inrelation to the medical device or other product. The alert signalprovided on expiry of the predetermined time period may indicate to theuser that the particular action needs to be taken. The action that needsto be taken may be removing or replacing the medical device or otherproduct, checking of the patient using the medical device or otherproduct, checking functioning of the medical device or other product,reviewing whether or not the device or other product should remain inplace and, if so, when it should next be reviewed, ceasing use of themedical device or other product or otherwise.

As indicated, in one embodiment the support surface to which the fixingportion is fixed may be provided by medical records of a patient. Byconfiguring the label to be fixed to medical records, the label may bereadily accessible by the user, and held in a secure location at leastduring the duration of monitoring of the predetermined time period. Ingeneral, a patient's medical records may remain in close proximity tothe patient at all times, e.g., through location in a records holder(usually at the end of the patient's bed), and medical records aretherefore readily and regularly accessible by medical staff. A patient'smedical records are a source of status information relating to thepatient, and therefore an ideal location for the label. This contrasts,for example, with placement of a monitoring system such as a timer onmedical device(s) attached to the patient, or placement directly on thepatient. In these circumstances, the monitoring system may be more proneto damage or interference, or may be more likely to cause damage orinterference to other equipment. For example, should the patient need toundergo a MRI scan, it may be necessary to remove any monitoring systemplaced on the patient, or on medical devices attached to the patient, toavoid interference with MRI apparatus. Further, when the monitoringsystem is placed on another medical device (e.g., an adhesive dressingor cannula line, etc.) that medical device may need to be replacedbefore the predetermined time period being monitored has ended, andbefore it is desirable to end monitoring of the predetermined timeperiod.

The medical records may comprise one or more sheet elements, e.g. sheetsof paper, plastic or card. The medical records may comprise a board,file or folder. The fixing portion may be planar to enable fixation to aplanar surface of the medical records.

The entire label or a part thereof may be designed for disposal afterexpiry of the predetermined time period. The label may be a single-uselabel.

The label may be associated with a specific medical device. The labelmay be associated with a medical device by being packaged and/orattached to the medical device prior to use. Additionally oralternatively, the label may be associated with a medical device bybeing labelled as specifically for use with the medical device, orlabelled as appropriate for use with that type of medical device, e.g.,by virtue of information displayed on the label and/or on documentationor packaging accompanying the label. Additionally or alternatively, thelabel may be associated with a medical device by being configured tomonitor a predetermined time period that is known to be relevant to thattype of medical device.

In some embodiments, the product relating to which the predeterminedtime period is monitored may be a substance or material that has aspecific expiry period or recommended usage period. For example, theproduct may be an ingestible substance, a pharmaceutical, a biologicallyactive agent, a monoclonal antibody, a disinfectant, a foodstuff and/orany other substance or material that has a specific expiry or usageperiod. When the product is a pharmaceutical, the pharmaceutical may bean antibiotic, probiotic, steroid, anaesthetic, antidepressant or anyother type of pharmaceutical. The pharmaceutical may be presented in theform of a fluid, tablet, capsule, powder or otherwise.

The product may be held in a container and the specific expiry or usageperiod may be initiated by opening of the container and/or breaking of aseal of the container. The container may be a sealed container that,once opened, should be discarded, or at least have its contentsdiscarded, after the specific expiry or usage period has ended. Thepredetermined time period monitored by the timer of the label maycorrespond exactly to or closely to the specific expiry or usage period.The container may be a bottle, packet, box, can, sachet or carton, forexample.

When the product relating to which the predetermined time period ismonitored is held in a container, the support surface to which the labelis to be fixed may be part of the container. The support surface may bean outer surface of the container, for example, so that the label, whenfixed to the support surface, is easily visible to a user.

In any aspect or embodiment described herein, the label may comprise afirst portion and a second portion. In some embodiments, the firstportion is separable from the second portion. All or part of the fixingportion may be comprised in the second portion and all or part of thesignalling apparatus may be comprised in the first portion.

According to one aspect of the present disclosure, there is provided alabel comprising:

a timer to monitor a predetermined time period relating to a product;

a signalling apparatus that provides an alert signal on expiry of thepredetermined time period; and

a fixing portion to fix the label to a support surface,

wherein the label comprises a first portion and a second portion, thefirst portion located towards a first end of the label and a secondportion located towards a second end of the label opposite to the firstend, and

wherein the signalling apparatus is comprised in the first portion andthe fixing portion is comprised in the second portion.

In any of the aspects above, in addition to the signalling apparatus,the first portion may comprise the timer. The label may further comprisea power source such as a battery to power the timer and the signallingapparatus. The first portion may also comprise the power source. In someembodiments, all electronic elements of the label may be comprised inthe first portion.

The first portion may be located towards a first end of the label andthe second portion may be located towards a second end of the label,opposite from the first end, along a longitudinal axis of the label. Byproviding a first portion that comprises the electronic elements and asecond portion that comprises the fixing portion, these two key portionsof the label may take substantially different forms. For example, thesecond portion may be maintained as a relatively flexible, flat and/ordiscreet portion of the label that can be fixed to a number of differentsupport surfaces, including contoured surfaces, while the first portionmay be maintained as a relatively inflexible and/or bulky portionsuitable for housing the electronics.

As indicated, in some embodiments, the first portion may be separablefrom the second portion. Provision of first and second portions that areseparable can allow the first portion to be removed or disconnected fromthe support surface (e.g. a surface of medical records, a surface of acontainer or otherwise) while the second portion remains fixed to thesupport surface. Various components of the label such as the signallingapparatus may be relatively bulky. Accordingly, by locating componentsin the first portion and permitting removal of the first portion fromthe second portion, e.g., after the predetermined time period hasexpired and the alert signal has been made, the second portion only mayremain permanently attached to the support surface. The second portionmay be relatively small and/or streamline in comparison to the firstportion. In addition to providing for a reduction in size of the label,removal of the first portion may provide a visual indication that themonitoring of the predetermined time period has expired and anynecessary action has been taken as a result of its expiry. Moreover,when the signalling apparatus or other electronic elements are locatedin the first portion, providing the option of removing the first portionfrom the second portion fixed to a support surface can assist with wastedisposal or recycling practices. For example, it may allow the medicalrecords, the container or any other item comprising the support surfaceto which the second portion of the label is fixed to be disposed of in afirst manner that is different from a second manner in which the firstportion is disposed of. For example, the first manner of disposal mayemploy general recycling, standard waste bins, paper shredders orotherwise, whereas the second manner of disposal may employ e-wasterecycling, etc.

By maintaining fixation of the second portion to the support surface,the second portion may provide a record in relation to the monitoring ofthe predetermined time period that remains part of the support surface,e.g. part of the medical records, the surface of a container orotherwise. For example, the second portion may comprise a displayportion to provide information relating to the medical device or otherproduct and/or information relating to the monitored predetermined timeperiod. The display portion may comprise a surface on which a user canwrite information and/or a surface on which information is pre-printed.

The first portion may be manually separated from the second portion. Thelabel may comprise a frangible element, tear line, tear notch,perforations and/or other region of weakness that enables manualseparation of the first and second portions. Thus, the first portion maybe torn from the second portion, for example. In addition to or as analternative to tearing, the first and second portions may be snappedapart, cut apart or otherwise. Cutting may involve use of scissors orother types of cutting elements.

By providing the fixing portion in the second portion, and by providingthe signalling apparatus in the first portion, the signalling apparatusmay be arranged to overhang an edge of the support surface while thesecond portion is fixed to the support surface, enabling easierobservation of the signalling apparatus, or at least an element thereof.

When the label is used with medical records, and the medical recordscomprise one or more sheets of paper, the second portion may be affixedto and locate directly over a first piece of paper while at least partof the first portion projects beyond an edge of the first piece ofpaper. If a second piece of paper were placed on top of the first pieceof paper, the second portion of the label may be covered by the paperbut the first portion of the label may remain visible. In anotherexample, when the medical records comprise a folder or binder, thesecond portion may be affixed to and locate directly over paper inside,or a wall of, the folder or binder, while at least part of the secondportion projects therefrom. Again, the first portion of the label may becovered while the second portion may remain visible. Accordingly,appropriate monitoring of the predetermined time period may continue,even as medical records are modified by a user.

When the label is used with a product located in a container, e.g., afirst container, the second portion may be affixed to and locatedirectly over a support surface of the first container while at leastpart of the first portion projects beyond the first container. If asecond container or other object is placed in close proximity to thefirst container, the second portion of the label may be covered by thatsecond container or other object but the first portion of the label mayremain visible. Accordingly, appropriate monitoring of the predeterminedtime period may continue.

Following from this, according to one aspect of the present disclosure,there is provided a label comprising:

a timer to monitor a predetermined time period relating to a product;

a signalling apparatus that provides an alert signal on expiry of thepredetermined time period; and

a fixing portion to fix the label to a support surface,

wherein the label comprises a first portion and a second portion, and

wherein the signalling apparatus is comprised in the first portion andthe fixing portion is comprised in the second portion, and wherein thefirst portion is configured to overhang the support surface when thefixing portion fixes the label to the support surface.

In any of the preceding aspects, the signalling apparatus may compriseone or more signalling elements that produce the alert signal.Signalling elements may comprise any one or more of a display, aloudspeaker, a vibration means, and a light, for example. The alertsignal may comprise any one or more of an audible signal, a visualsignal and a tactile signal, for example. The display may comprise anyone or more of an LCD display, LED display, plasma display and E-inkdisplay, for example. The light may comprise an LED or light bulb, forexample.

When a display is provided, the display may provide an indication of thedegree to which the predetermined time period has elapsed followingcommencement of monitoring of the predetermined time period (e.g., acountdown of time, a count up of time or other visual indicator). Wherethe display is used to provide an alert signal upon expiry of thepredetermined time period, the display may flash or provide some otherreadily identifiable warning signal.

When a loudspeaker is provided, the loudspeaker may issue an alertsignal by sounding, e.g., by beeping loudly.

When a light is provided, the light may issue an alert signal by turningon, turning off or flashing on and off.

A first type of alert signal may be issued prior to expiry of thepredetermined time period and a second type of alert signal may beissued upon expiry of the predetermined time period. The first type ofalert signal may indicate that the predetermined time period is beingmonitored prior to expiry, whereas the second type of alert signal mayindicate that the predetermined time period has expired. The first typeof alert signal may therefore be different from the second type of alertsignal.

The first type of alert signal may be continually emitted prior toexpiry of the predetermined time period, periodically emitted prior toexpiry, or emitted only upon an actuation step being carried out by theuser. The second type of alert signal may be continually emitted uponexpiry of the predetermined time period, periodically emitted uponexpiry of the predetermined time period, or emitted only upon anactuation step being carried out by the user. The actuation step inrelation to the first and/or second alert signal may comprise pressingof a button comprised in the label, for example. The actuation step maytherefore enable a user to interrogate the status of the label, e.g., tocheck if the label is still monitoring the time period and/or to checkif the predetermined time period has expired. The use of the actuationstep may provide an energy saving measure.

In one embodiment, the signalling apparatus comprises one or more lightsthat emit light of a first colour as the first type of alert signal,e.g., green light, and which emit light of a second colour, e.g., redlight, as the second type of alert signal. The first colour light may beemitted automatically upon initiation of the monitoring of thepredetermined time period but may remain off for a majority of thepredetermined time period thereafter, except when a user carries out theactuation step to interrogate the status of the label. On the otherhand, upon expiry of the predetermined period, the second colour lightmay be emitted continually or periodically over an extended period oftime (e.g., until the power source comprised in the label fullydischarges), so that a user is readily made aware that the predeterminedtime period has expired and action in relation to an associated medicaldevice or other product may need to be taken.

In any of the preceding aspects, the fixing portion may compriseadhesive, e.g., an adhesive layer, to fix the label to the supportsurface. The fixing portion may comprise a backing layer that isremovable to expose the adhesive and place the label in a state forfixing to the support surface. Alternative fixing portions may beprovided, however, e.g., depending on the nature of the support surfaceto which the label is to be fixed. For example, the fixing portions maycomprise a hook/loop fastener, a magnet, a clip or otherwise. Wherefirst and second portions are provided, in some embodiments the fixingportion may extend on a rear surface of the second portion, but not arear surface of the first portion.

In embodiments of the present disclosure, a variety of approaches may betaken to cause initiation of monitoring of the predetermined time periodby the timer. For example, the label may comprise an actuator such as abutton or a slider that is pressed by a user to start the monitoring, orcomprise a tab that is removed to start the monitoring. In someembodiments, the fixing portion may be moveable between a first stateand a second state. Moving of the fixing portion from the first state tothe second state may place the fixing portion in a condition for fixingthe label to the support surface and initiate monitoring of the timeperiod by the timer.

Following from this, according to another aspect of the presentdisclosure, there is provided a label comprising:

a timer to monitor a predetermined time period relating to a product;

a signalling apparatus that provides an alert signal on expiry of thepredetermined time period; and

a fixing portion to fix the label to a support surface,

wherein the fixing portion is moveable between a first state and asecond state,

wherein moving the fixing portion from the first state to the secondstate places the fixing portion in a condition for fixing the label tothe support surface and initiates monitoring of the predetermined timeperiod by the timer.

As indicated above, the fixing portion may comprise adhesive and abacking layer that is removable to expose the adhesive and place thelabel in a state for fixing to the support surface. Thus, in someembodiments, the fixing portion may be moved from the first state to thesecond state by removal of the backing layer from the adhesive andremoval of the backing layer may cause initiation of the monitoring ofthe predetermined time period. The backing layer may be connected to aswitch that turns the timer on upon removal of the backing layer. As analternative, the backing layer or a tab connected to the backing layer,may be interposed between an electrical contact and a terminal of apower source e.g., a battery that powers at least the timer. While it isinterposed between the contact and terminal, it may prevent electricityfrom being supplied to the timer. Upon removal of the backing layer andoptional tab, electricity may begin to flow to the timer, causingmonitoring of the predetermined time period to start.

A similar approach may be taken where the fixing portion is not involvedin initiation of monitoring of the predetermined time period by thetimer. For example, a tab may be interposed between a contact and aterminal of the power source, but the tab may accessible to the usersuch that the user can remove the tab, e.g., by pulling the tab.

In one aspect, the present disclosure provides medical recordscomprising the label.

The medical records may comprise one or more sheet elements of paper,plastic or card, wherein the label is fixed to the one or more sheetelements.

In another aspect, the present disclosure provides a containercomprising the label.

The container may comprise a substance or material that has a specificexpiry period or recommended usage period such as an ingestiblesubstance, a pharmaceutical, biologically active agent, monoclonalantibody, disinfectant, foodstuff and/or other substance. The containermay be a sealed container that, once opened, should be discarded, or atleast have its contents discarded, after the specific expiry or usageperiod has ended. The container may be a bottle, packet, box, can,sachet or carton, for example. The label may be fixed to an outersurface of the container.

In aspects described above, among other things, a medical device labelis disclosed that is adapted to be fixed to medical records of apatient. As indicated, the medical records may be a common type ofmedical records, comprising sheets of paper located in a folder, forexample. Nevertheless, in some embodiments, an article may be providedthat is pre-configured to receive the medical device label. In someembodiments, the article may be designed to interact electrically withthe medical device label. The article may be a base station forreceiving the medical device label, for example. In some embodiments,components of the medical device label as described above may be presentin the base station.

Following from this, according to an aspect of the present disclosure,there is provided a monitoring system for a medical device, comprising:

a base station; and

a medical device label receivable by the base station;

wherein the monitoring system monitors a predetermined time periodrelating to a medical device based on receipt of the medical devicelabel by the base station.

The base station may perform the monitoring of the predetermined timeperiod, the label may perform the monitoring of the predetermined timeperiod and/or a combination of the base station and the label mayperform the monitoring of the predetermined time period.

According to one aspect of the present disclosure, there is provided abase station configured to receive a medical device label and monitor apredetermined time period relating to a medical device based on thereceipt of the medical device label.

According to another aspect of the present disclosure, there is provideda medical device label configured to be received by a base station thatmonitors a predetermined time period relating to a medical device basedon the receipt of the medical device label.

The monitoring system, e.g., the base station of the monitoring system,may include a timer or timing module to monitor the predetermined timeperiod. The timer or timing module may monitor for expiry of thepredetermined time period by counting up to or counting down from thepredetermined time period.

The base station may be usable with a plurality of different medicaldevices simultaneously and/or sequentially. A plurality of the medicaldevice labels may be provided, wherein each label is associated with arespective one of the plurality of medical devices. Additionally oralternatively, a plurality of the medical device labels may be provided,wherein each label is associated with the same medical device. The basestation may be adapted to receive multiple labels simultaneously and/orsequentially and monitor multiple predetermined time periods based onreceipt of the plurality of labels by the base station.

The medical device label may comprise a display portion. The displayportion may include information about the associated medical deviceand/or the predetermined time period. Information may be provided on thedisplay portion in a hand-written or printed format. Additionally oralternatively, the display portion may comprise an electronic display,e.g., an LCD or E-ink display, that displays the information.

The label may be designed for disposal after expiry of the predeterminedtime period. The label may be a single-use label. On the other hand, thebase station may be re-used after expiry of the predetermined timeperiod.

The base station may be patient-specific. In this regard, where multiplelabels are received by the base station, each label may be associatedwith a medical device that is used in relation to the same patient.Alternatively, the base station may be usable in relation to multiplepatients.

The label and the base station may comprise electrical components. Thebase station and the label may comprise electric contacts that contacteach other and establish electrical communication between the basestation and the label when the label is received by the base station.The monitoring system, e.g., the base station of the monitoring system,may monitor the predetermined time period upon establishment of anelectrical connection between electrical components of the base stationand the label. Monitoring may start automatically on establishment ofthe electrical connection or following further action by the user, suchas the pressing of a button that is optionally included in the basestation or label. The base station and the label may comprise electriccontacts that contact each other to establish electrical communicationbetween the base station and the label when the label is received by thebase station. Alternatively, the base station and the label may compriseinduction coils that inductively couple with each other to establishelectrical communication between the base station and the label when thelabel is received by the base station.

Information about the predetermined time period may be comprised in thebase station. For example, the base station, e.g. a timer in the basestation, may be preconfigured with the predetermined time period. Thismay be appropriate if the base station is to be used with a medicaldevice or medical devices for which only one predetermined time periodis relevant.

Additionally or alternatively, information about the predetermined timeperiod may be comprised in the label. The base station may identify thepredetermined time period based on information provided by the label.The base station may identify the predetermined time period at leastpartially based on receipt of the label. This may be appropriate if thebase station is to be used with a medical device or medical devices forwhich a variety of different predetermined time period are relevant.Information may be provided from the label to the base station via anelectrical signal, an optical signal, a wireless signal, and/or by ashape or configuration of the label or otherwise.

To enable information to be provided from the label to the base stationby virtue of an electrical signal, an electrical connection between thelabel and the base station may be established on receipt of the label bythe base station. Information about the predetermined time period may beencoded in an electrical signal sent from the label to the base station.A digitally encrypted signal may be provided by the label, e.g., from anelectronics chip comprised in the label, to the base station and thebase station may decode the digital signal to obtain information aboutthe predetermined time period. Alternatively, the electrical signal maybe a measurement signal. The base station may identify the predeterminedtime period by performing a measurement in relation to the label. Forexample, one or more electrical components of the base station maymeasure an electrical property of one or more electrical components ofthe label and identify the predetermined time period based on themeasurement. For example, the label may comprise one or more resistors.An electrical signal may be transmitted across the one or more resistorsand the voltage drop across the one or more resistors may be determinedby the base station. Depending on the size of the voltage drop, andtherefore the size of the resistor, the base station may identify thepredetermined time period. Through use of a resistor to provideinformation about the predetermined time period, rather than e.g., adigitally encrypted signal provided by an electronics chip, the labelmay be better configured for sterilisation, using processes such asgamma radiation. Subjecting the label to a gamma radiation sterilisationprocess could corrupt any digital information stored in the label, butwould not cause a change in the resistance of the resistor.

To enable information to be provided from the label to the base stationby virtue of an optical signal, the base station may comprise a readerthat is adapted to read an identifier on the label. The identifier maybe a barcode or QR code, for example, and the reader may be configuredto scan the identifier. The reader may read the identifier upon receiptof the label by the base station, or prior to or after receipt of thelabel.

To enable information to be provided from the label to the base stationby virtue of a wireless signal, the label may comprise a transmitter andthe base station may comprise a receiver. Radio-frequency signals orblue-tooth signals, etc., which contain information about thepredetermined time period, may be transmitted from the label to the basestation.

To enable information to be provided from the label to the base stationby a shape or configuration of the label, the base station may beconfigured to sense a shape or configuration of the label upon receiptof the label. Different sensed shapes or configurations of the label maybe indicative of different predetermined time periods.

One of the base station and the label may comprise a power source, e.g.,a battery. The power source may power electrical components of the basestation and the label. The power source may be located in the label yetmay power electrical components of the base station. In some instances,the base station may not comprise a power source. It can be particularlyadvantageous to provide the power source in the label to ensure that apower source with a sufficiently high stored energy level is present inthe monitoring system at the time that monitoring of the predeterminedtime period is required. Since a label may be configured for single useonly, the energy available from the power source can be expected to beat a relatively high level when the label is used. On the other hand, ifthe power source is comprised in the base station, to the extent thatthe base station is usable multiple times with a plurality of differentlabels, for example, there is a greater possibility that the storedenergy would be at a relatively low level. The power source maytherefore have insufficient energy to power electrical components forthe duration of the predetermined time period. While the power sourcemay be replaceable or rechargeable, or the base station may be connectedto a mains supply, convenience to the user may be increased throughprovision of the power source within the label.

The monitoring system may have a substantially planar shape. The basestation and/or the label may have a substantially planar shape. Byhaving a substantially planar shape, storage of the monitoring systemand/or components thereof may be straightforward. The monitoring systemmay be locatable in a holder, e.g., a document holder such as a medicalrecords holder, which may be located at the end of a patient's bed orotherwise. The records holder may be a folder such as a ring binder. Inone embodiment, the base station is a ring binder insert. The basestation may include a plurality of holes for engaging rings of the ringbinder. The monitoring system may be locatable in other types ofholders, however, such as a wall-mounted holder or a desk-mountedholder. In some healthcare environments, it is known to write patientrecords or general patient data on a whiteboard. The monitoring systemmay be locatable in a holder that is mounted on or adjacent to awhiteboard.

By configuring the monitoring system for location within a holder, suchas a medical records holder, the monitoring system may be readilyaccessible by the user (e.g., a nurse, doctor or clinician, etc.), andheld in a secure location at least during the duration of monitoring ofthe predetermined time period. In accordance with discussions above, themonitoring system may comprise signalling apparatus that provides analert signal on expiry of the predetermined time period. Additionally,an alert signal may be provided by the signalling apparatus at one ormore scheduled times in the lead-up to expiry of the predetermined timeperiod or subsequent to expiry of the predetermined time period.

The base station may comprise the signalling apparatus or the label maycomprise the signalling apparatus, or the signalling apparatus may beshared by the base station and the label. Additionally or alternatively,the signalling apparatus may be partially or entirely comprised in anexternal device that is separate from the base station and the label,such as a computer device. The monitoring system may communicate withthe external device via a communications network, e.g., via theinternet, Wi-Fi, Bluetooth, or otherwise. The computer device may formpart of a computer system of a hospital or clinic, etc., where themonitoring system is used.

The signalling apparatus may comprise one or more signalling elementsthat produce the alert signal. Signalling elements may comprise any oneor more of a display, a loudspeaker, a vibration means, and a light, forexample. The alert signal may comprise any one or more of an audiblesignal, a visual signal and a tactile signal, for example. The displaymay comprise any one or more of an LCD display, LED display, plasmadisplay and E-ink display, for example. The light may comprise an LED orlight bulb, for example.

When a display is provided, the display may provide an indication of thedegree to which the predetermined time period has elapsed followingcommencement of monitoring of the predetermined time period (e.g., acountdown of time, a count up of time or other visual indicator). Wherethe display is used to provide an alert signal upon expiry of thepredetermined time period, the display may flash or provide some otherreadily identifiable warning signal.

When a loudspeaker is provided, the loudspeaker may issue an alertsignal by sounding, e.g., by beeping loudly.

When a light is provided, the light may issue an alert signal by turningon, turning off or flashing on and off.

In one embodiment, the signalling apparatus comprises the display andthe light, which are each configured to provide an alert signalsimultaneously upon expiry of the predetermined time period.

As indicated, the base station may be adapted to receive a plurality ofthe labels at the same time. In this instance, the signalling apparatusmay comprise multiple signalling elements, a different one of thesignalling elements being used in relation to each one of the labels. Bytaking this approach, a user may be able to identify which of aplurality of different time periods being monitored simultaneously hasor have expired, and/or the degree to which those predetermined timeperiods have elapsed. In one embodiment, the signalling apparatuscomprises multiple displays, each display being for use with arespective one of the labels.

The base station may comprise a receiving portion and the label maycomprise an engagement portion. The base station may receive the labelby virtue of engagement, e.g., releasable engagement, between thereceiving portion and the engagement portion. One of the receivingportion and the engagement portion may comprise a recess and the otherof the receiving portion and the engagement portion may comprise aprotrusion that is adapted to be received in the recess to achieve theengagement. For example, the receiving portion may comprise the recessand the engagement portion may comprise the protrusion. The receivingportion may be held in engagement with the engagement portion by virtueof a friction fit. Additionally or alternatively, the receiving portionmay be held in engagement with the receiving portion by adhesion,hook-and-loop fastening, magnetism or otherwise.

The receiving portion and the engagement portion may each compriseelectrical contacts that form an electrical connection between the basestation and the label upon engagement between the receiving portion andthe engagement portion. Transfer of power and/or information between thebase station and the label may be via the electrical connection.

When the base station is configured for use with multiple labels, thebase station may comprise a plurality of the receiving portions, eachadapted to engage with an engagement portion of a respective one of thelabels.

The label may comprise a housing and an electronics unit located in thehousing. The housing may define the engagement portion of the label. Thelabel may comprise the display portion adapted to display informationabout the medical device and/or predetermined time period. The housingmay protrude relative to the display portion. The display portion may beremovable from a portion of the label that comprises the housing. Thelabel may comprise a tear line to enable the removal of the displayportion. The display portion may comprise an adhesive, e.g., on an outersurface thereof. Removal or separation of the display portion can allowthe display portion to be placed in medical records of a patient, orplaced in a different part of medical records of a patient, after use ofthe label. The adhesive may enable attachment of the display portion tomedical records.

According to one aspect of the present disclosure, there is provided amedical device label comprising a power source and an engagementportion, the engagement portion being adapted to engage a receivingportion of a base station to establish an electrical connection betweenthe power source and the base station.

The label of this aspect may comprise any one or more features of thelabel described above with respect to preceding aspects.

Throughout this specification the word “comprise”, or variations such as“comprises” or “comprising”, will be understood to imply the inclusionof a stated element, integer or step, or group of elements, integers orsteps, but not the exclusion of any other element, integer or step, orgroup of elements, integers or steps.

BRIEF DESCRIPTION OF DRAWINGS

By way of example only, embodiments are now described with reference tothe accompanying drawings, in which:

FIGS. 1a and 1b shows front and rear oblique views of a label accordingto an embodiment of the present disclosure;

FIG. 2 shows an exploded view of the label;

FIG. 3 shows a rear oblique view of an electronics unit of the label;

FIG. 4 shows a rear oblique view of the label with a backing layerpartially peeled off;

FIG. 5 shows a front oblique view of the label with the backing layercompletely peeled off but with the backing layer connected to theremainder of the label by a tab;

FIG. 6 shows a front oblique view of the label with the backing layercompletely peeled off and the tab removed from the remainder of thelabel;

FIG. 7 shows a front oblique view of the label attached to medicalrecords;

FIG. 8 shows a front oblique view of the label attached to medicalrecords with a first portion of the label removed from a second portionof the label;

FIG. 9 shows a schematic illustration of components of the electronicsunit of the label;

FIG. 10a shows a rear oblique view of a label according to anotherembodiment of the present disclosure; FIG. 10b shows a rear oblique viewof the label of FIG. 10a with a tab pulled from the label; and FIG. 10cshows a rear oblique view of an electronics unit of the label of FIG. 10a;

FIG. 11a shows an oblique view of a medical device monitoring system,including a base station and a label, according to an embodiment of thepresent disclosure, the monitoring system being located in a patientrecords holder; and FIG. 11b shows a cross-sectional view of themonitoring system along line A-A in FIG. 11 a;

FIG. 12 shows an oblique exploded view of the monitoring system of FIG.11 a;

FIGS. 13a, 13c and 13d show front, side and rear views, respectively, ofthe label of FIG. 10a ; and FIG. 13b shows a cross-sectional view of thelabel along line A-A in FIG. 13 a;

FIG. 14 shows an oblique exploded view of the label of FIG. 11 a;

FIGS. 15a and 15b show front and rear views, respectively, of anelectronics unit of the label of FIG. 11 a;

FIG. 16 shows a schematic illustration of various electrical componentsof the monitoring system of FIG. 11 a;

FIG. 17 shows an oblique view of the monitoring system of FIG. 11a heldin the patient records holder while the patient records holder is in aclosed configuration; and

FIG. 18 shows a front view of a container having a label fixed theretoaccording to another embodiment of the present disclosure.

DESCRIPTION OF EMBODIMENTS

Oblique front and rear views of a label 1 according to an embodiment ofthe present disclosure are shown in FIGS. 1a and 1b . The label 1includes a timer to monitor a predetermined time period relating to aproduct and specifically, in the present embodiment, a medical device.The label may therefore be considered a medical device label 1. Thelabel 1 includes a signalling apparatus that provides an alert signal onexpiry of the predetermined time period, and a fixing portion to fix thelabel to medical records of a patient.

The medical device label 1 in this embodiment is associated with amedical device such as an intravascular cannula that is to be insertedin a patient for a period of time, e.g., in a hospital environment. Thelabel can be packaged with the medical device prior to use of the labeland medical device. A cannula is an example of an invasive medicaldevice that should be located in a patient for no longer than a maximumsafe period (e.g., 24 hours, 72 hours, 7 days or otherwise), as governedby medical standards, protocols or regulations applicable to theenvironment where it is used (e.g., hospital, ambulance or clinic,etc.), or manufacturer's guidelines for the medical device. By limitingindwelling of a medical device such as a cannula to a maximum safeperiod or less, the risk of the patient contracting a HAI can besignificantly reduced.

Following from this, in the present embodiment, the timer is adapted tomonitor a predetermined time period (e.g., 24 hours) that corresponds tothe maximum safe period for indwelling of an associated medical device.The monitoring of the predetermined time period is triggered by a useraction in relation to the label as discussed further below. Monitoringof the predetermined time period may comprise counting up or countingdown the predetermined time period using the timer.

The medical device is not necessarily an invasive, indwelling device ora device prone to causing infection, however. In alternativeembodiments, the medical device label may be associated with any medicaldevice for which monitoring of a predetermined time period is desirable.For example, the medical device may be a compression bandage or a drugdelivery patch that should be removed within a specific period of time.As another example, the medical device may be a hospital bed, wherein apatient lying on the bed should be encouraged to move periodically toavoid pressure sores. Moreover, in alternative embodiments, the label 1may be used to monitor other products such as a substance or materialthat has a specific expiry period or recommended usage period. Forexample, the product may be an ingestible substance, a pharmaceutical, abiologically active agent, a monoclonal antibody, a disinfectant, afoodstuff and/or any other substance or material that has a specificexpiry or usage period. Further discussion of such use of the label isprovided further below with reference to FIG. 18.

Referring to FIGS. 1a and 1b , the label 1 has a substantially planarconfiguration, with substantially rectangular front and rear surfaces111, 112, a first end 113, a second end 114, a first side 115 and asecond side 116. The length direction of the label 1 extends between thefirst and second ends 113, 114 and the width direction of the labelextends between the first and second sides 115, 116.

As can be seen from the exploded view of FIG. 2, the label 1 generallyhas a three-layer construction, including a front panel 12, a rear panel13 and a releasable backing layer 14. The rear panel 13 includesadhesive on a rear surface 131 thereof, which is covered prior to use bythe releasable backing layer 14. Release of the backing layer 14 exposesthe adhesive, enabling the rear surface 131 to be fixed to medicalrecords or another support surface. In this regard, the adhesiveprovides part of a fixing portion of the label.

In the length direction of the label, the front and rear panels 12, 13are each divided into a first portion 101 and a second portion 102, thefirst and second portions 101, 102 being located at opposite sides of atear line 103. The first portion 101 is located toward the first end 113of the label and the second portion 102 is located towards the secondend of the label 114. The tear line extends between the first and secondsides 115, 116 of the label 1 in the width direction of the label 1. Thefirst portion 101 is smaller than the second portion 102. Both the firstportion 101 and the second portion 102 extend across the full width ofthe label 1. The second portion 102 extends across a greater portion ofthe label 1 in the length direction of the label 1 than the firstportion 101. The first portion 101 is separable from the second portion102 by virtue of a user tearing along the tear line 103.

The label 10 is substantially flat, except at a region of the secondportion 102 of the label 1 where the label 1 includes a housing 20 foran electronics unit 21. The housing 20 is formed by a section of thefront panel 12 and an opposing relief 201 formed in the rear panel 13,the relief 201 projecting rearward relative to the remainder of the rearpanel 13. The backing layer 14 includes an opening 141 through which thehousing 20 projects. The relief 201 is shaped to both enclose theelectronics unit 20 and form a button 202 that is accessible by a user.

With reference to FIGS. 2 and 3, the electronics unit 21 located in thehousing 20 comprises a printed circuit board (PCB) 211 on which abattery 212 is mounted along with an LED 213, a processor (microchip)214 and a test switch 215, the test switch 215 being positionedunderneath the button 202 in the relief 201. The battery 212 provides asource of power for the LED 213 and processor 214. Electricity istransferred to the LED 213 and processor 214 via an electrical circuitincluding the PCB 211. The electrical circuit is connected to thebattery 212 by a first electrical contact (not visible) and a secondelectrical contact 216. The first electrical contact is positioned onthe PCB 211, underneath the battery 212, to electrically contact a firstterminal of the battery 212. The second electrical contact 216 is in theform of a flexible conductive arm and forms a bridge from the PCB 211over the battery 212 to electrically contact a second terminal of thebattery 212. The second electrical contact 216 also clips the battery212 in place, holding it firmly in position against the PCB 211.

As can be seen most easily in FIG. 3, a removable, non-conductive tab217 is positioned under the battery between the first terminal of thebattery 212 and the first electrical contact of the PCB 211. While thetab 217 remains in this position, the first electrical contact isinsulated from the first terminal of the battery 212 by the tab 217 andthe electrical circuit is therefore incomplete (open). In this state,electricity cannot flow from the battery 212 to the processor 214 andLED 213. However, when the tab 217 is removed, the first terminal of thebattery 212 and the first electrical contact are configured to touch soas to complete (close) the electrical circuit. When complete,electricity can flow from the battery 212 to the processor 214 and LED213. The LED 213 is visible at the front surface 111 of the label 1through a small window 121 in the front panel 12 that aligns with asmall window 2111 in the PCB 211, adjacent the mounting position of theLED 213 on the PCB 211. The LED 213 forms part of signalling apparatusthat provides an alert signal on expiry of the predetermined timeperiod, as discussed further below.

In this embodiment, removal of the tab 217 provides a trigger for thetimer to start monitoring the predetermined time period. The timer isprovided by a timing module 2141 within the processor 214, and isconfigured to start timing when electricity is supplied to the processor214 from the battery 212. The timing module 2141 is represented in FIG.9, which provides a schematic illustration of electrical components ofthe label 1.

The label 1 is configured so that removal of the backing layer 14 fromthe label 1 causes the removal of the tab 217 from its positionunderneath the battery 212. The tab 217 is connected to the backinglayer adjacent the first end 113 of the label 1. At the opposite end 114of the label 1, the backing layer 14 includes a grip portion 142 thatprojects beyond the first and second panels 12, 13 of the label. Thegrip portion 142 is easily accessible and engageable by the user. Tostart using the medical device label, a user can take hold of the gripportion 142 to peel the backing layer 14 from the rear panel 14 of thelabel, in a direction towards the first end 113 of the label 1 asrepresented in FIG. 4. When the backing layer 14 is initially peeled offthe rear panel 13, it remains connected to the front and rear panels 12,13 of the label via the tab 217 as shown in FIG. 5. However, furtherpulling of the backing layer 14 pulls the tab 217 from its positionunderneath the battery 212. This separates the backing layer 14 from thefront and rear panels 12, 13 and triggers the monitoring of thepredetermined time period as discussed above.

When the backing layer 14 is peeled off it exposes the adhesive on therear surface 131 of the rear panel 13. The adhesive is positioned onlyon the rear surface 131 of the second portion 102 of the label 1 and notthe first portion 101 of the label 1. The adhesive provides part of afixing portion to fix the second portion 102 of the label 1 to medicalrecords or other support surface. Removal of the backing layer 14 toexpose the adhesive essentially causes the fixing portion to move from afirst state to a second state. Only in the second state is the fixingportion made ready to fix the label 1 to medical records or othersupport surface. Moving of the fixing portion from the first state tothe second state, by virtue of removal of the backing layer 14, causesinitiation of the monitoring of the predetermined time period asdiscussed above.

By fixing the label 1 to medical records, for example, the label 1 canbe readily accessible by a user and held in a secure location at leastduring the duration of monitoring of the predetermined time period. Ingeneral, a patient's medical records can remain in close proximity tothe patient at all times, e.g., through location in a records holder(usually at the end of the patient's bed), and it is therefore readilyand regularly accessible by medical staff. A patient's medical recordsare a source of status information relating to the patient, andtherefore an ideal location for the medical device label 1. Thiscontrasts, for example, with placement of a monitoring system such as atimer on medical device(s) attached to the patient, or placementdirectly on the patient. In these circumstances, the monitoring systemmay be more prone to damage or interference, or may be more likely tocause damage or interference to other equipment. For example, should thepatient need to undergo a MRI scan, it may be necessary to remove anymonitoring system placed on the patient, or on medical devices attachedto the patient, to avoid interference with MRI apparatus. Further, whenthe monitoring system is placed on another medical device (e.g., anadhesive dressing or cannula line, etc.) that medical device may need tobe replaced before the predetermined time period being monitored hasended, and before it is desirable to end monitoring of the predeterminedtime period.

FIG. 7 shows the label 1 fixed to medical records 3 that include a sheetof paper 31 held in a folder 32. The second portion 102 of the label 1is fixed to the sheet of paper 31 while the first portion 101 projectsbeyond (overhangs) the edge of the paper 31. In this embodiment, thefirst portion 101 also projects beyond the edge of the folder 32. Ifanother piece of paper were placed on top of the paper 31, the secondportion 102 of the label 1 may be covered by the paper but the firstportion 101 of the label can remain visible. Accordingly, appropriatemonitoring of the predetermined time period may continue, even asmedical records are modified by a user.

As indicated, the signalling apparatus that provides an alert signal onexpiry of the predetermined time period comprises the LED 213. Referringto FIG. 9, further componentry of the signalling apparatus is providedby a signalling module 2142 in the processor 214. In this embodiment,the LED 213 is a bi-colour LED that is operable to selectively emit redand green light. The red light provides a first type of alert signal andthe green light provides a second type of alert signal. After expiry ofthe predetermined time period as monitored by the timer, the signallingmodule 2142 causes the LED 213 to emit red light, providing an alert tothe user that the predetermined time period has ended and thatappropriate action needs to be taken.

After initiation of monitoring of the predetermined time period, andprior to expiry of the predetermined time period, the signalling module2142 is adapted to cause the LED 213 to emit green light. Green light isemitted by the LED 213 for a brief period at the start of monitoring ofthe predetermined time period (i.e. upon removal of the non-conductivetab 217), but the LED 213 remains off thereafter until an optionalactuation step is carried out by the user or until the predeterminedtime period expires. The actuation step comprises a user pressing thebutton 202 such as to depress the switch 215 of the electronics unit 21.Pressing of the button 202 enables a user to interrogate the status ofthe label, e.g., to check if the label is still monitoring thepredetermined time period. If the button 202 is pressed while thepredetermined time period is being monitored, prior to expiry of thepredetermined time period, the LED 213 will emit green light. Byemitting green following user interrogation, rather than continuously upto expiry of the predetermined time period, energy usage from thebattery 212 can be reduced. Reducing energy usage reduces the risk thatthe battery 212 will discharge prior to expiry of the predetermined timeperiod.

Upon expiry of the predetermined period, the red light is emitted fromthe LED 213 in a flash or continuous mode for an extended period of time(e.g., until the battery 212 fully discharges). This ensures that a useris readily made aware that the predetermined time period has expired andthat action in relation to an associated medical device needs to betaken.

In alternative embodiments, e.g., where there is sufficient batterypower, the green light may remain on during monitoring of thepredetermined time period or may flash intermittently during monitoringof the predetermined time period. The green light may flash every 30seconds, for example. In accordance with this, in some embodiments theswitch and button may be excluded from the label.

As indicated above, through the provision of the tear line 103 betweenthe first and second portions 101, 102 of the label 1, the first andsecond portions 101, 102 are separable from each other. Separation ofthe first and second portions 101, 102 is also made possible by theadhesive contact between the label and the medical records 3 occurringat the second portion 102 of the label only. By allowing separation ofthe first portion 101 from the second portion 102, the first portion 101can be removed from the medical records 3 after expiry of thepredetermined time period and once action in relation to the medicaldevice has been taken. Separation of the first portion 101 from thesecond portion 102 is represented in FIG. 8. The removed first portion101 may be discarded. The first portion of the label 101 comprises therelatively bulky housing 20 and electronics unit 21. By removing thefirst portion 101 including the relatively bulky housing 20 andelectronics unit 21, and leaving behind a relatively streamlined secondportion 102 of the label 1 only, the medical records 3 may be maintainedin a more compact form. Further, removal of the first portion 101 canprovide a visual indication to the user that the monitoring of thepredetermined time period by the label 1 has expired and any necessaryaction has been taken as a result of the expiry. Still further, removalof the first portion 101 allows the first portion 101, including theelectronics unit 21, to be disposed of in a suitable manner, e.g. usinge-waste recycling, while the second portion 102 and the medical records3 (or any other item to which the label 1 is attached) can be disposedof by other suitable means, e.g. using general recycling, standard wastebins, paper shredders or otherwise.

At the second portion 102 of the label, the front surface 111 of thelabel provides a surface that includes pre-printed details relating tothe medical device associated with the label and the predetermined timeperiod. In an alternative embodiment, all or a part of the front surfaceof the second portion 102 is left blank, allowing a user to writedetails thereon. Thus, by maintaining fixation of the second portion 102to the medical records, the second portion 102 may continue to provide arecord relating to the monitoring of the predetermined time period. Asan example, when then the medical device is an indwelling device, andthe predetermined time period that is monitored by the label 1corresponds to the maximum period that is considered safe for indwellingof the medical device, the second portion 102 may provide a record of:the time and date of insertion of the medical device into the patient; aname or identifier of the person that inserted the medical device intothe patient; the type of the medical device; the positioning of themedical device; and/or the date and time of removal of the medicaldevice.

It will be appreciated by persons skilled in the art that numerousvariations and/or modifications may be made to the above-describedembodiments, without departing from the broad general scope of thepresent disclosure.

For example, additional or alternative fixing portions may be provided,e.g., depending on the nature of the medical records or other supportsurface to which the label is to be fixed. For example, the fixingportions may comprise a hook/loop fastener, a magnet, a clip orotherwise.

As another example, the signalling apparatus may comprise additional oralternative signalling elements that produce the alert signal, such as adisplay, a loudspeaker and/or vibration means or otherwise. In additionor as an alternative to an audible signal, the alert signal may includea visual signal and/or a tactile signal or otherwise.

As yet another example, alternative approaches may be taken to causeinitiation of monitoring of the predetermined time period by the timer.For example, the label may comprise a modified tab, or an actuator suchas a button or a slider that is pressed, pulled, or moved by a user tostart the monitoring.

An embodiment of a label 1′ according to present disclosure in which thelabel 1′ includes a modified tab 217′ is illustrated in FIGS. 10a to 10c. The label 1′ is configured in a similar manner to the label 1 of thepreceding embodiment as illustrated in FIGS. 1 to 9, with the tab 217′being partially located under a battery 212′ to prevent completion of anelectrical circuit. The battery 212′ forms part of an electronics unit21′ (FIG. 10c ), that includes a printed circuit board (PCB) 211′ onwhich the battery 212′ is mounted. The electronics unit 21′ againlocates in a housing 20′ of the label 1′. However, in this embodiment,the tab 217′ is not connected to a backing layer such that removal ofthe backing layer causes pulling and therefore removal of the tab.Instead, the tab 217′ extends through a slot 132′ in a rear panel 13′ ofthe label 1′ as illustrated in FIG. 10a , enabling a user to directlyengage and pull the tab 217′, e.g., with a thumb and forefinger. Pullingthe tab 217′ from the slot as illustrated in FIG. 10b causes the tab217′ to be released from its location underneath the battery 212′ andtherefore causes the electrical circuit to be completed. Upon completionof the electrical circuit, the monitoring of the predetermined timeperiod is initiated.

To make it easier for a user to engage the tab 217′, the tab 217′ isprovided with a length greater than the length of the tab 217 shown inFIG. 3, for example. Moreover, to improve usability, an indication ofthe appropriate direction for pulling of the tab 217′ is providedthrough the forming of pointed end 2171′ to the tab 217′. The pointedend 2171′ points away from the battery 212′. Additionally oralternatively, indicia may be printed on the tab 217′ to assist theuser, including words such as “REMOVE TO ACTIVATE” or similar.

In this embodiment, the label 1′ again has a first portion 101′ and asecond portion 102′, the first portion 101′ being separable from thesecond portion 102′. Moreover, the label 1′ again has primarily athree-layer construction, including a front panel, a rear panel 13′ anda releasable backing layer 14′ attached to adhesive on the rear panel13′. However, the adhesive and the backing layer 14′ extend over therear panel 13′ at the second portion 102′ of the label 1′ only, whilethe tab 217′ extends through the slot 132′ that is located in the rearpanel 13′ at the first portion 101′ of the label′. Accordingly, the tab217′ and the slot 132′ are not obstructed by the adhesive and backinglayer 14′, ensuring that removal of the tab 217′ via the slot 132′ isnot impeded.

A front view of a container 70 having a label 80 fixed thereto accordingto another embodiment of the present disclosure is illustrated in FIG.18. The label 80 is very similar to the labels 1, 1′ described abovewith reference to FIGS. 1a to 10b . However, so that the label 80 fitsmore easily on the container 70, the label 80 is provided with a shorterlength.

Therefore, like the labels 1, 1′ described above, the label 80 includesa first portion 801 and a second portion 802, the first and secondportions 801, 802 being located at opposite sides of a tear line 803.The first portion 801 includes some or all of the electronics of thelabel 80 for monitoring a predetermined time period and issuing an alertsignal upon expiry of the time period, and the second portion 802includes a fixing portion such as an adhesive layer for fixing the label80 to the container 70. The second portion 802 of the label 80 is fixedto an outer surface of the container 70 that provides a support surfacefor the label 80. The first portion 801 of the label projects from oroverhangs the container 70.

The container 70 houses a product that has a specific expiry or usageperiod after opening of the container. In particular, in thisembodiment, the container 70 is a sealed bottle that contains a liquidpharmaceutical such as an antibiotic that should be discarded, or atleast not used, a set number of days after opening of the bottle (e.g.,7 days, 14 days, 28 days after opening or otherwise), preventing use ofthe pharmaceutical before it becomes overly contaminated, functionallydegraded or otherwise inappropriate for consumption. The label 80 isselected to monitor a corresponding time period. Once the time periodexpires, the label 80 provides the alert signal to a patient, clinicianor other user.

Through the provision of the tear line 803 between the first and secondportions 801, 802 of the label 80, the first portion 801 can be removedfrom the container 70, e.g., after expiry of the predetermined timeperiod. The removed first portion 801 may be discarded. Removal of thefirst portion 801 can provide a visual indication to the user that themonitoring of the predetermined time period by the label 1 has expiredand any necessary action has been taken as a result of the expiry andcan also assist with waste disposal in accordance with discussionsabove.

In alternative embodiments of the label 80, however, the first andsecond portions 801, 802 may not be configured to be separable (they mayhave no tear line 803, for example). Nevertheless, by providing a firstportion 801 that comprises the electronic elements and a second portionthat comprises the fixing portion, these two key portions of the labelcan be maintained in substantially different form. For example, thesecond portion can be maintained as a relatively flexible, flat and/ordiscreet portion of the label that is fixable to a relatively contouredsupport surface of a bottle or otherwise, while the first portion can bemaintained as a relatively inflexible and/or bulky portion suitable forhousing the electronics.

An oblique view of a medical device monitoring system 4 according toanother embodiment of the present disclosure is shown in FIG. 11a . Themonitoring system 4 includes a base station 40 and a medical devicelabel 50 that is receivable by the base station 40. In this embodiment,the base station 40 is in the form of a ring binder insert having asubstantially planar shape, and includes a plurality of holes forengaging rings 61 of a ring binder 60.

The medical device label 50 is associated with a medical device such asan intravascular cannula that is to be inserted in a patient for aperiod of time, e.g., in a hospital environment. The label 50 can bepackaged with the medical device prior to use of the label and medicaldevice. A cannula is an example of an invasive medical device thatshould be located in a patient for no longer than a maximum safe period(e.g., 24 hours, 72 hours, 7 days or otherwise), as governed by medicalstandards, protocols or regulations applicable to the environment whereit is used (e.g., hospital, ambulance or clinic, etc.), ormanufacturer's guidelines for the medical device. By limiting indwellingof a medical device such as a cannula to a maximum safe period or less,the risk of the patient contracting a HAI can be significantly reduced.

The base station 40 is adapted to monitor a predetermined time periodbased on receipt of the label 50 by the base station 40. In thisembodiment, the predetermined time period that is monitored is themaximum safe period for indwelling of the medical device.

The medical device is not necessarily an invasive, indwelling device ora device prone to causing infection, however. In alternativeembodiments, the medical device may be any medical device for whichmonitoring of a predetermined time period is desirable. For example, themedical device may be a compression bandage or a drug delivery patchthat should be removed within a specific period of time. As anotherexample, the medical device may be a hospital bed, wherein a patientlying on the bed should be encouraged to move periodically to avoidpressure sores.

An exploded oblique view of the monitoring system 4 including the basestation 40 and label 50 is provided in FIG. 12. FIGS. 13a to 13d providefurther views of the label 50. The label 50 has a substantially planarshape with a front surface 511, a rear surface 521, a first end 53 and asecond end 54. Each of the front and rear surfaces 511, 521 issubstantially flat, except at regions toward the first end 53 of thelabel 50, where the label includes a housing 55 for an electronics unit56. The housing 55 is provided in a first portion 581 of the labellocated towards the first end 53. A second portion 582 of the label 50is located towards the second end 54 and is separable from the firstportion 581 by tearing along a tear line 583. At the second portion 582,the front surface 511 of the label 50 provides a surface that includespre-printed details relating to the medical device associated with thelabel and the predetermined time period. In an alternative embodiment,all or a portion of the front surface of the second portion may be leftblank, allowing a user to write details thereon. In general, the secondportion 582 may be considered a display portion of the label.

An exploded view of the label 50 is shown in FIG. 14. The label includesa front panel 51 that defines the front surface 511 of the label 50. Onan opposite side of the front surface 511, the front panel 51 has aninner surface 512. The label 50 also has a rear panel 52 that definesthe rear surface 521 of the label 50. On an opposite side of the rearsurface 521, the rear panel 52 has an inner surface 522. The innersurfaces 512, 522 of the front and rear panels 51, 52 are adapted tocontact (e.g., adhere to) each other to form the label 50, whereupon thehousing 55 is assembled and the electronics unit 56 is securely heldwithin the housing 55.

The housing 55 is defined by a circular relief 513 in the front panel 51that is raised with respect to the front surface 511 of the front panel51, and a circular relief 523 in the rear panel 52 that is raised withrespect to the rear surface 521 of the rear panel 52. The circularrelief 523 in the rear panel 52 has an opening 524, surrounded by a rim525.

The electronics unit 56 is shown in more detail in FIGS. 15a and 15b andincludes a battery 561 and a printed circuit board (PCB) 562, thebattery 561 being mounted on an inner surface 5621 of the PCB 562. Afirst electrical contact 5622 is positioned on the inner surface 5621 ofthe PCB 562, and locates underneath the battery 561 and electricallycontacts a first terminal of the battery 561. A second electricalcontact 5623, in the form of a resiliently flexible conductive arm,projects from the inner surface 5621 of the PCB 562, and extends overthe battery 561 and electrically contacts a second terminal of thebattery 561. The second electrical contact 5623 clips the battery 561 inplace, holding it against the inner surface 5621 of the PCB 562. Theelectronics unit 56 includes first, second and third circular contacts5624, 5625, 5626 positioned concentrically on the outer surface 5627 ofthe PCB 562. The first electrical contact 5622 is electrically connectedto the first circular contact 5624 and the second electrical contact5623 is electrically connected to the second circular contact 5625.

An additional electrical component, in particular a resistor 5628, isprovided on the PCB 562 to provide information to the base station aboutthe predetermined time period. First and second terminals of theresistor 5628 are electrically connected to the first and third circularcontacts 5624, 5626. In this regard, the first circular contact 5624provides an electrical ground contact for both the battery 562 and theresistor 5628.

In combination, the relief 523 of the rear panel 52 and the outersurface 5627 of the PCB 562 can be considered to provide an engagementportion of the label 50, indicated in FIGS. 13b and 13c by referencenumeral 57.

When the electronics unit 56 is securely held within the housing 55, theelectronics unit 56 is sandwiched between inner surfaces of the reliefs513, 523, whereupon the outer surface 5627 of the PCB 562 abuts againstthe rim 525, leaving a substantial portion of the outer surface 5627 ofthe PCB 562, including the first, second and third circular contacts5624, 5625, 5626 exposed through the opening 524.

The base station 40 includes a front surface 41, and a plurality ofreceiving portions, in particular recesses 42, provided on the frontsurface 41. Each recess 42 is adapted to receive the engagement portion57 of a respective label 50 by virtue of a frictional fit, as can beseen in FIG. 11b , for example. By providing a plurality of the recesses42, the base station 40 can receive multiple labels 50 at the same time,each label being associated with a different medical device or differentfeatures of the same medical device. FIG. 11a includes a magnified viewof one of the recesses 42. Each recess 42 has a bottom surface 420 witha plurality of electrical contacts 421 a-423 b projecting from thebottom surface 420. Upon receipt of an engagement portion 57 of a label50 by a recess 42, two of the projecting electrical contacts 421 a, 421b are adapted to connect with the first circular contact 5624, anothertwo of the projecting electrical contacts 422 a, 422 b are adapted toconnect with the second circular contact 5625, and another two of theprojecting electrical contacts 423 a, 423 b are adapted to connect withthe third circular contact 5626. These connections establish a powercircuit between the base station 40 and the battery 561 of the label 50,and establish a resistance measurement circuit between the base station40 and the label 50.

A schematic illustration of various electrical components of themonitoring system 4, including the base station 40 and labels 50 a, 50 breceived by the base station 40, is provided in FIG. 16. For simplicity,FIG. 16 shows only two labels 50 a, 50 b and two displays 44 a, 44 b(each display 44 a, 44 b being for use with a respective one of thelabels 50 a, 50 b). In practice, to the extent that the base station 40is adapted to receive a different number of labels (e.g., adapted toreceive five labels, as represented in FIG. 11a ) a corresponding numberof displays would be present. Substantially the same principles ofoperation of the system 4 can apply, regardless of the number of theplurality of labels.

The base station 40 comprises a controller 45 (e.g., a microcontroller)that is connected to each one of the displays 44 a, 44 b and to an LED46. The controller controls the visual output of the displays 44 a, 44 band illumination of the LED 46. When each label 50 a, 50 b is receivedby the base station 40, a respective power circuit is establishedbetween the controller 45 and the battery of the label 50 a, 50 b, whichpower circuit can be turned on and off by the controller using a switch47 a, 47 b (e.g., a MOSFET). The controller 45 recognises the receipt ofa label 50 a, 50 b based on establishment of the power circuit with thelabel 50 a, 50 b.

Upon establishment of the power circuit with the label 50 a, 50 b, thecontroller 45 determines a predetermined time period that is to bemonitored in relation to the label 50 a, 50 b and more particularly themedical device associated with that label. Each label 50 a, 50 bprovides information to the controller 45 about the predetermined timeperiod using its resistor 5628 a, 5628 b. The controller 45 includes atime period recognition module 452, which measures the resistance of theresistor 5628 a, 5628 b (e.g., by virtue of a voltage drop measurement)using the resistance measurement circuit established between the basestation 40 and the label 50 a, 50 b. The time period recognition module452 determines the predetermined time period based on the measuredresistance. In this embodiment, the time period recognition module 452is adapted to recognise that a measured resistance falling within afirst resistance range is indicative of a first predetermined timeperiod (e.g., 24 hours), a measured resistance falling within a secondresistance range is indicative of a second predetermined time period(e.g., 48 hours), a measured resistance falling within a thirdresistance range is indicative of a third predetermined time period(e.g., 72 hours), and measured resistance falling within a fourthresistance range is indicative of a fourth predetermined time period(e.g., 7 days). In general, however, there is no limit to the number ofpredetermined time periods that the base station may be configured torecognise based on different resistance measurements. Further, differentpredetermined time periods can be any appropriate predetermined timeperiods.

The controller includes a plurality of timing modules 453 a, 453 b,which are each associated with a respective one of the received labels50 a, 50 b. Once the predetermined time period for a received label 50a, 50 b is identified by the time period recognition module 452, thecontroller 45 inputs the predetermined time period to the associatedtiming module 454 a, 454 b. The timing module then counts down thepredetermined time period. The countdown may start substantiallyimmediately on receipt of the label 50 a, 50 b by the base station 40,after a pre-set delay, or upon receipt of a user input (e.g., uponpressing by the user of a button that is optionally included in the basestation 40).

The controller 45 controls each display 44 a, 44 b to display thecountdown of the predetermined time period for the label 50 a, 50 bassociated with that display. This provides the user with a visualindication of the time left to expiry of the predetermined time period.Upon expiry of the predetermined time period, the controller 45 isadapted to cause the display 44 a, 44 b to flash (e.g., flash a zerotime display “0:00:00” and/or a word such as “FINISHED”) and cause theLED 46 to flash. While the same LED 46 is used in relation to multiplereceived labels 50 a, 50 b in this embodiment, the LED 46 may still drawa user's attention to the fact that a predetermined time period hasexpired in relation to at least one of the received labels 50 a, 50 b.The user may then observe which display(s) 44 a, 44 b is flashing, andthus identify the label(s) in relation to which a predetermined timeperiod has expired.

Upon recognition that a predetermined time period relating to a label 50a, 50 b has expired, the user may take a particular action in relationto the medical device that is associated with the label 50 a, 50 b. Forexample, if the medical device is a catheter, the user may remove andoptionally replace the catheter. Once the predetermined time period hasexpired for a particular label 50 a, 50 b, that user can remove thelabel 50 a, 50 b from the base station 40. The second portion 582 of thelabel, which may include details of the associated medical device asdiscussed above, can be separated from the first portion 581 and placedin medical records of a patient. The second portion 582 may have anadhesive portion to enable attachment to medical records.

In this embodiment, when the base station 40 is in receipt of multiplelabels 50 a, 50 b at the same time, the battery 561 a, 561 b of only oneof the received labels 50 a, 50 b is used to power components of thesystem 4, including the controller 45, displays 44 a, 44 b and LED 46.To determine which battery 561 a, 561 b of the multiple labels 50 a, 50b to use to power the components, the controller 45 includes a poweranalysis module 451, which scores (ranks) each battery 561 a, 561 b,based on a determination of the battery voltage (indicative of theenergy remaining in the battery) and a determination of the remainingtime left of the predetermined time period that is being monitored inrelation to the label 50 a, 50 b associated with the battery 561 a, 561b. The battery 561 a, 561 b offering the best combination of highbattery voltage and shortest remaining time is selected, and the powercircuit associated with the selected battery is turned on using theassociated switch 47 a, 47 b. The approach ensures that, even if a labelis unexpectedly removed from the base station 40 at any point in time,the system 4 will still have access to sufficient power from otherbatteries 561 a, 561 b to continue to monitor predetermined timeperiods.

Generally, it will be recognised that a controller used in conjunctionwith a monitoring system according to an embodiment of the presentdisclosure can comprise a number of control or processing modules forcontrolling one or more components of the system and may also includeone or more storage elements, for storing data such as predeterminedtime period data. The modules and storage elements can be implementedusing one or more processing devices and one or more data storage units,which modules and/or storage devices may be at one location (e.g., in abase station as shown in FIG. 16) or distributed across multiplelocations (e.g., in both a base station and label) and interconnected byone or more communication links.

The modules can be implemented by a computer program or program codecomprising program instructions. The computer program instructions caninclude source code, object code, machine code or any other stored datathat is operable to cause the controller to perform the steps described.The computer program can be written in any form of programming language,including compiled or interpreted languages and can be deployed in anyform, including as a stand-alone program or as a module, component,subroutine or other unit suitable for use in a computing environment.The data storage device(s) may include suitable computer readable mediasuch as volatile (e.g., RAM) and/or non-volatile (e.g., ROM, disk)memory or otherwise.

In the embodiment illustrated in FIG. 11a , the LED 46 is located at atop corner of the base station 40. The arrangement is such that, whenthe monitoring system, 4 including the base station 40 is held in thering binder 60, and the ring binder 60 is closed as shown in FIG. 17,the LED 46 projects outwardly from the ring binder 60 and thereforeremains visible to the user.

The ring binder 60 provides a form of patient or medical records holder.By configuring the monitoring system 4 for location within a recordsholder, the monitoring system 4 may be readily accessible by the user(e.g., a nurse, doctor or clinician, etc.), and held in a securelocation at least during the duration of monitoring of the predeterminedtime period(s). In general, a medical records holder will remain inrelatively close proximity to the patient at all times (usually at theend of the patient's bed, outside their room or at a nurses' station),and it is there readily and regularly accessible by medical staff.Fundamentally, the medical record is a source of status informationrelating to the patient, and therefore an ideal location for themonitoring system.

It will be appreciated by persons skilled in the art that numerousvariations and/or modifications may be made to above-describedembodiments, without departing from the broad general scope of thepresent disclosure.

For example, while, in the main embodiment of the monitoring system 4described above, the base station 40 is adapted to identify apredetermined time period based on a resistance measurement, a varietyof different approaches to identifying the predetermined time period maybe employed, such as by communication of a coded signal from a chip thatmay be include in the label to the base station, or via an opticalsignal, a wireless signal, and/or by a shape or configuration of thelabel or otherwise. Alternatively, the base station may bepre-configured to monitor a single predetermined time period only.

As another example, while, in the main embodiment of the monitoringsystem 4 described above, the base station 40 is adapted to receivemultiple labels, in alternative embodiments the base station may beadapted to receive a single label only. It may therefore include onlyone receiving portion to engage with a label.

As yet another example, while, in the main embodiment of the monitoringsystem 4 described above, the system is powered by a battery in a label,in alternative embodiments the base station may include a battery orother power source (e.g., a mains power connection) to at least partlypower the monitoring system.

As yet another example, while, in the main embodiment of the monitoringsystem 4 described above, the system is adapted to locate in a ringbinder, the monitoring system in this or alternative embodiments may beconfigured to locate in other types of holders, such as a wall-mountedholder or a desk-mounted holder. In some healthcare environments, it isknown to write patient records (or patient data) on a whiteboard. Themonitoring system may be locatable in a holder that is mounted on oradjacent to a whiteboard.

The present embodiments are, therefore, to be considered in all respectsas illustrative and not restrictive.

1. A label comprising: a timer to monitor a predetermined time periodrelating to a product; a signalling apparatus that provides an alertsignal on expiry of the predetermined time period; and a fixing portionto fix the label to a support surface, wherein the label comprises afirst portion and a second portion, the first portion located towards afirst end of the label and a second portion located towards a second endof the label opposite to the first end, and wherein the signallingapparatus is comprised in the first portion and the fixing portion iscomprised in the second portion.
 2. The label of claim 1, wherein thefirst portion is separable from the second portion.
 3. The label ofclaim 2 comprising a frangible element, tear line, tear notch,perforations and/or region of weakness between the first portion and thesecond portion to enable separation of the first portion from the secondportion.
 4. The label of claim 1, wherein the product is a medicaldevice.
 5. The label of claim 1, wherein the support surface is providedby patient medical records.
 6. The label of claim 5, wherein the medicalrecords comprise one or more sheet elements of paper, plastic or card.7. The label of claim 5, wherein the first portion is arranged tooverhang an edge of the medical records when the label is fixed to themedical records by the fixing portion.
 8. The label of claim 1, whereinthe product is a substance or material located in a container.
 9. Thelabel of claim 8, wherein the support surface is provided by a surfaceof the container.
 10. The label of claim 1, wherein the fixing portionis planar.
 11. The label of claim 1, wherein the label is a single-uselabel.
 12. The label of claim 1, wherein the label comprises a powersource and the power source, timer and signalling apparatus arecomprised in the first portion.
 13. The label of claim 1, wherein thesecond portion comprises a display portion. including a surface on whicha user can write information and/or a surface on which information ispre-printed.
 14. The label of claim 1, wherein the signalling apparatusis configured to provide a first type of alert signal prior to expiry ofthe predetermined time period and a second type of alert signal uponexpiry of the predetermined time period, the first and second types ofalert signal being different.
 15. The label of claim 14, wherein thefirst type of alert signal is emitted upon an actuation step beingcarried out by a user.
 16. The label of claim 14, wherein the actuationstep comprises pressing a button comprised in the label.
 17. The labelof claim 1, wherein the label comprises a tab that is removable toinitiate monitoring of the predetermined time period by the timer. 18.The label of claim 1, wherein the fixing portion is moveable between afirst state and a second state, wherein moving the fixing portion fromthe first state to the second state places the fixing portion in acondition for fixing the label to the support surface and initiatesmonitoring of the predetermined time period by the timer.
 19. The labelof claim 1, wherein the fixing portion comprises adhesive covered by aremovable backing layer.
 20. The label of claim 18, wherein the fixingportion comprises adhesive covered by a removable backing layer andwherein removal of the backing layer moves the fixing portion from thefirst state to the second state.